[M16-191] Myelofibrosis: Phase 3 Study of Navitoclax Plus Ruxolitinib Versus Ruxolitinib

JRCT ID: jRCT2041210045

Registered date:30/07/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Myelofibrosis
• Date of first enrollment: 28/07/2021
• Target sample size: 23
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Canada,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Russia,Japan,Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan,Bulgaria,Japan,Croatia,Japan,Greece,Japan,New Zealand,Japan,Serbia,Japan,South Africa,Japan,Turkey,Japan,Ukraine,Japan
• Study type: Interventional

Intervention(s)

Experimental: Arm A: Navitoclax + Ruxolitinib
- Participants will receive Navitoclax in combination with Ruxolitinib
Active Comparator: Arm B: Placebo for Navitoclax + Ruxolitinib
- Participants will receive placebo for Navitoclax and Ruxolitinib

Outcome(s)

• Primary Outcome: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health Organization (WHO) classification or Secondary MF (post polycythemia vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) .
- Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days prior to randomization.
-- Must have at least 2 symptoms with a score >=3 or a total score of >=12, as measured by the MFSAF v4.0.
- Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
- Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan.
-Ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant and other criteria per National Comprehensive Cancer Network guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclude criteria

- Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.
- Prior treatment with a BH3-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant.
- Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 milligram daily) and low molecular weight heparin (LMWH).

Related Information

• Primary Sponsor: Tsutsui Atsuko
• Secondary ID(s): NCT04472598